Events

Recall of Device Recall AXIOM Artis

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73589
  • Event Risk Class
    Class 2
  • Event Number
    Z-1310-2016
  • Event Initiated Date
    2016-02-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144543
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, x-ray, fluoroscopic, image-intensified - Product Code JAA
  • Reason
    Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. this leak can occur sporadically in affected systems.
  • Action
    Siemens mailed out an Important Customer Safety Notice to customers informing them of a corrective action that will be performed to prevent a possible leak in the detector cooling system of Axiom Artis and Artis zee systems. The notice stated the affected plastic couplings will be replaced with metal couplings to prevent fluid leaks. Siemen's service organization will contact each customer to arrange a date to perform the corrective action. Customers asked to call 1-800-888-7436 to schedule an appointment for the corrective action to be implemented.

Device

Device Recall AXIOM Artis
  • Model / Serial
    Model Numbers: 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392, 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and Puerto Rico
  • Product Description
    AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA